Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-01-22 @ 11:18 PM
Study NCT ID:
NCT02391467
Status:
SUSPENDED
Last Update Posted:
2015-10-02
First Post:
2015-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity of Elastography During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'issue concerning safety of elastography during pregnancy', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-30', 'studyFirstSubmitDate': '2015-03-12', 'studyFirstSubmitQcDate': '2015-03-17', 'lastUpdatePostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between the fibrosis score during and after pregnancy', 'timeFrame': '3 to 6 months after delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis B Virus Infection; Pregnant Women']}, 'descriptionModule': {'briefSummary': 'Non invasive methods are the only available methods to stage liver fibrosis during pregnancy. The safety of elastometry - ultrasound based - is obvious, as medical supervision of pregnancy is based on ultrasonography, both methods using same wavelengths. Therefore, this method is sometimes used in pregnant women with recent diagnosis of chronic viral hepatitis infection, whereas its validity in pregnant women has never been studied. This lack of data justifies our study.', 'detailedDescription': 'One measurement during the third trimester of pregnancy will be compared to a second measurement, 3 months after childbirth.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women with HBV or HCV chronic hepatitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women\n* Followed in Obstetrics Dpt\n* HBV or HCV chronic hepatitis\n* After information and written consent\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02391467', 'briefTitle': 'Validity of Elastography During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Lariboisière'}, 'officialTitle': 'Validity of Non-invasive Liver Fibrosis Assessment by Ultrasound-based Elastography at the Third Trimester of Pregnancy: a Prospective Study', 'orgStudyIdInfo': {'id': 'Liver006'}}, 'contactsLocationsModule': {'locations': [{'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Lariboisiere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Pierre O SELLIER, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Lariboisiere, Paris, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Lariboisière', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Paris VII University, Paris, France', 'investigatorFullName': 'Stephane Mouly, MD PhD', 'investigatorAffiliation': 'Hopital Lariboisière'}}}}